BROMAZEPAM 1.5 mg Tablet

Зміст інструкції

1. BROMAZEPAM PENSA 1.5 mg tablets
   1. WHAT IS BROMAZEPAM PENSA AND WHAT IS IT FOR:
   2. WHAT YOU NEED TO KNOW BEFORE TAKING BROMAZEPAM PENSA
   3. HOW TO TAKE BROMAZEPAM PENSA
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE BROMAZEPAM PENSA
   6. PACKAGE CONTENTS AND OTHER INFORMATION

BROMAZEPAM PENSA 1.5 mg tablets

BROMAZEPAM PENSA 3 mg tablets
BROMAZEPAM PENSA 2.5 mg/ml oral drops, solution
Generic medicine

Read this leaflet carefully before taking this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What BROMAZEPAM PENSA is and what it is used for
• 2. What you need to know before you take BROMAZEPAM PENSA
• 3. How to take BROMAZEPAM PENSA
• 4. Possible side effects
• 5. How to store BROMAZEPAM PENSA
• 6. Contents of the pack and other information

1. WHAT IS BROMAZEPAM PENSA AND WHAT IS IT FOR:

BROMAZEPAM PENSA contains bromazepam, belonging to the class of medicines called
“benzodiazepines” with anxiolytic action.
Benzodiazepines are used to relieve severe states of anxiety, which subject the individual
to severe discomfort.
This medicine is used to treat:

• anxiety, tension and other disorders associated with anxiety
• sleep disorders (insomnia)

Benzodiazepines are indicated only when the disorder is severe, disabling and subjects the
individual to severe discomfort.

2. WHAT YOU NEED TO KNOW BEFORE TAKING BROMAZEPAM PENSA

Do not take BROMAZEPAM PENSA:

• if you are allergic to bromazepam, to other similar medicines (benzodiazepines) or to any of the other ingredients of this medicine (listed in section 6)
• if you are allergic to benzodiazepines (a class of medicines to which bromazepam belongs)
• if you suffer from myasthenia gravis (a serious illness that affects the muscles and manifests with weakness and fatigue)
• if you suffer from severe respiratory failure (a serious reduction in the activity of the respiratory system)
• if you suffer from severe liver problems (severe hepatic insufficiency)
• if you suffer from sleep apnea syndrome (temporary cessation of breathing during sleep.
• if you suffer from narrow-angle glaucoma (an eye disease caused by an increase in the pressure of the fluid contained within the eye);
• if you are taking an excessive amount of alcohol (acute alcohol intoxication)
• if you are taking an excessive amount of medicines:
• Hypnotics (medicines that calm and stimulate sleep)
• Analgesics (medicines for the treatment of acute or chronic pain of high intensity)
• Psychotropics (medicines used for mental disorders and/or depression

Warnings and precautions
Consult your doctor or pharmacist before taking BROMAZEPAM PENSA.
In particular, consult your doctor or pharmacist beforetaking Lexotan if you think that one of the following conditions applies to you:

• you suffer from depression or anxiety related to depression, because Lexotan may worsen your condition and may lead to the onset of suicidal thoughts (attempting to kill yourself);
• you have had problems with drug or alcohol abuse in the past;
• if you are addicted to alcohol or use opioids (medicines used for pain);
• if you have previously developed a severe allergic reaction after the administration of a benzodiazepine (anaphylactic/anaphylactoid reaction);
• you suffer from chronic respiratory failure (reduction of the activity of the respiratory system);
• you suffer from renal insufficiency (reduction of kidney function);
• you suffer from severe hepatic insufficiency (severe reduction of liver function);
• you suffer from heart failure (reduced heart function);
• you suffer from low blood pressure;
• you suffer from a mental disorder that causes an altered perception of reality, thought disorders, mental confusion (psychosis).

Development of tolerance:Following repeated use of this medicine for a prolonged period, a decrease in its effectiveness (tolerance) may occur.

Development of dependence:The use of high doses and/or for prolonged periods of BROMAZEPAM PENSA may cause physical and psychological dependence. This risk is greater if you have previously abused medicines, drugs or alcohol (especially in poly-drug abusers). The possibility of dependence is reduced if you use BROMAZEPAM PENSA at the appropriate dose, as prescribed by your doctor and with a short-term treatment (see section 3 “How to take BROMAZEPAM PENSA”).

If you are elderly
If you are elderly, take BROMAZEPAM PENSA with caution and under medical supervision.
This medicine may increase the risk of falls and fractures due to undesirable effects such as ataxia (reduced motor and gait coordination), muscle weakness, dizziness, drowsiness, fatigue.

Children and adolescents
Benzodiazepines should not be given to patients under the age of 18

Other medicines and Bromazepam Pensa
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Tell your doctor or pharmacist if you are taking any of the following medicines:

• medicines used for some mental illnesses (antipsychotics/neuroleptics)
• medicines for the treatment of depression (antidepressants, such as fluvoxamine)
• calming and sleep-inducing medicines (hypnotics)
• medicines that cause physical and mental torpor (anxiolytics/sedatives)
• medicines for the treatment of acute or chronic pain of high intensity (narcotic analgesics)
• medicines used for cough (opioid antitussives)
• medicines for the treatment of epilepsy (antiepileptics)
• medicines to counteract allergic manifestations (sedative antihistamines)
• anesthetics
• cimetidine (a medicine used in case of stomach ulcer);
• theophylline or aminophylline (medicines used against bronchial asthma);
• antimycotics (medicines used for infections caused by fungi), protease inhibitors (medicines used for HIV therapy), macrolides (a type of antibiotics)
• propranolol (a medicine used to treat various types of heart problems)

The concomitant use of bromazepam with alcohol and/or medicines that depress the central nervous system must be avoided. The concomitant use has the power to increase the clinical effects of bromazepam, including severe sedation, respiratory and/or cardiovascular depression that is clinically relevant.
The concomitant use of BROMAZEPAM PENSA and opioids (powerful painkillers, medicines for substitution therapy for dependence and some medicines for cough) increases the risk of drowsiness, breathing difficulties (respiratory depression) and coma, and is potentially life-threatening. For this reason, concomitant use should only be considered when other therapeutic options are not possible.
However, if your doctor prescribes BROMAZEPAM PENSA together with opioids, the dose and duration of concomitant treatment must be limited by your doctor.
Tell your doctor about all opioid-based medicines you are taking and carefully follow their recommendations on dosage. It may be helpful to inform friends or family members so that they are aware of the signs and symptoms listed above.
Consult your doctor if you experience these symptoms.

BROMAZEPAM PENSA with food, drinks and alcohol:
Do not drink alcohol while taking this medicine, because the sedative effect of the medicine may be increased.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy
The safety of use of bromazepam in pregnancy has not yet been established.
In some studies, an increased risk of congenital malformations has been observed following the use of other benzodiazepines or similar substances during the first trimester of pregnancy.
Treatment with benzodiazepines at high doses during the second and/or third trimester of pregnancy may cause a decrease in fetal movements and alterations in the fetal heart rate.
If you are planning a pregnancy and are being treated with Bromazepam Pensa, contact your doctor immediately who will tell you how to gradually stop using this medicine.
If Bromazepam Pensa is administered during the last period of pregnancy, or during labor, hypothermia (reduction of body temperature), hypotonia (reduction of muscle tone) and respiratory depression or apnea (absence of respiratory movements) may occur in the newborn. In addition, newborns born to mothers who have chronically taken benzodiazepines during the advanced stages of pregnancy may develop physical dependence and may experience some risk of developing withdrawal symptoms in the postnatal period, such as hyperexcitability, agitation and tremor even a few days after birth

Breastfeeding

Do not takethis medicine if you are breastfeeding, because bromazepam passes into breast milk.

Driving and operating machinery
Do not drive or operate machinery if you experience side effects such as sedation (physical and mental relaxation), amnesia (memory disorders), alteration of concentration and muscle function while taking BROMAZEPAM PENSA. These effects are also worsened if you take alcohol with BROMAZEPAM PENSA (see section “BROMAZEPAM PENSA and alcohol”).
Your vigilance may be altered, especially if your sleep duration has been insufficient after taking BROMAZEPAM PENSA.

BROMAZEPAM PENSA tablets contain lactose:
If your doctor has diagnosed you with an intolerance to some sugars, contact him before taking this medicine.

BROMAZEPAM PENSA drops contain propylene glycol:
This medicine contains 962 mg of propylene glycol per 1 ml
Talk to your doctor or pharmacist before giving this medicine, especially if you are taking other medicines containing propylene glycol or alcohol.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise recommended by your doctor. The doctor may perform further checks during therapy.
If you suffer from liver or kidney disease, do not take this medicine unless otherwise recommended by your doctor. The doctor may perform further checks during therapy.

3. HOW TO TAKE BROMAZEPAM PENSA

Take this medicine following exactly the instructions of your doctor or pharmacist.
If you have any doubts, consult your doctor or pharmacist.

Adults
The doctor will establish the dose and frequency most suitable for you, in order to avoid the possible
intake of an excessive dose of this medicine.
The recommended dose is:

• tablets:1-2 tablets of 1.5 mg two to three times a day or 1 tablet of 3 mg two to three times a day,
• drops:15-30 drops two to three times a day.

Duration of treatment
The doctor will prescribe the shortest possible duration of treatment.
Depending on the indication for which the doctor has prescribed this medicine, the duration
of treatment is as follows:

Anxiety
The duration of treatment should not exceed 8-12 weeks, including a period of gradual withdrawal.

Insomnia
The duration of treatment ranges from a few days to two weeks, up to a maximum of four
weeks, including a period of gradual withdrawal. In certain cases, the doctor, after having
re-evaluated your health status, may decide to extend the duration of treatment
above indicated.
During the withdrawal period from BROMAZEPAM PENSA, the doctor will
explain how to gradually reduce the dose of this medicine in order to reduce the risk
that you experience withdrawal and rebound symptoms. See sections “If you stop taking
BROMAZEPAM PENSA” and “POSSIBLE SIDE EFFECTS”.

If you take more BROMAZEPAM PENSA than you should:
In case of ingestion/accidental intake of an excessive dose of BROMAZEPAM PENSA,
immediately notify your doctor or go to the nearest hospital.

Symptoms
Benzodiazepines commonly cause drowsiness, ataxia (reduced motor and
gait coordination), dysarthria (speech disorder) and nystagmus (oscillatory, rhythmic and
involuntary eye movements).
Bromazepam overdose can rarely pose a risk to life if the
drug is taken alone, but can lead to dysarthria (words pronounced slowly and
defectively), areflexia (absence of reflexes), apnea (absence of breathing), hypotension
(low blood pressure), cardiorespiratory depression (reduced activity of the heart and lungs) and
coma (loss of consciousness).
In mild cases, the symptoms in case of ingestion/accidental intake of an excessive dose of
BROMAZEPAM PENSA may be:

• drowsiness;
• mental confusion;
• lethargy (continuous sleep and reduced response to normal stimuli). In more severe cases, the symptoms may be:
• ataxia (reduced motor and gait coordination);
• hypotonia (reduction of muscle tone);
• hypotension (low blood pressure);
• respiratory depression (reduction of breathing);
• coma (loss of consciousness);
• death.

If you forget to take BROMAZEPAM PENSA
Do not take a double dose to make up for the missed dose.

If you stop taking BROMAZEPAM PENSA
Do not stop taking BROMAZEPAM PENSA without first consulting your doctor.
The doctor will gradually reduce the dose during the phase of suspension of therapy.
Abrupt discontinuation of this medicine can cause:

• withdrawal symptoms:headache, diarrhea, muscle pain, tension, severe anxiety, confusion, restlessness, irritability.
• severe withdrawal symptoms:derealization (sensation of perceiving the external world in a distorted way), depersonalization (sensation of detachment or estrangement from oneself), hyperacusis (increased sensitivity to sounds), numbness and tingling of the extremities (of hands and feet), hypersensitivity to light, noise and physical contact, hallucinations (perception of non-existent things in reality) or seizures.
• other withdrawal symptoms: depression, insomnia, sweating, persistent tinnitus (ringing in the ears), involuntary movements, vomiting, paresthesia (sensation of tingling), perceptual alterations (alteration of perceptions), abdominal and muscle cramps, tremor, myalgia (muscle pain), agitation, palpitations (sensation of increased heartbeat), tachycardia (increased heart rate), panic attacks, dizziness, hyper- reflexia (exaggeration of reflexes), short-term memory loss (ability to memorize recent events), hyperthermia (increased body temperature).
• rebound symptoms: (when the symptoms that led to treatment with bromazepam reappear in a more severe form after stopping treatment) such as mood changes, anxiety, restlessness or sleep disturbances.

These symptoms occur especially if you have developed a physical dependence on this medicine
(see section “Warnings and precautions”).
If you have any doubts about the use of this medicine, consult your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
Contact your doctor immediately if you experience any of the following serious side effects during treatment with BROMAZEPAM PENSA, your doctor will explain how to stop using the
medicine:

• Depression
• restlessness
• agitation
• irritability
• aggression
• distorted perception of reality (delirium)
• rage
• nightmares and abnormal dreams
• perception of things that do not exist in reality (hallucinations)
• behavioral changes
• psychosis (a mental disorder that causes an altered perception of reality, thought disorders, mental confusion)
• nervousness
• anxiety
• hyperactivity.

These reactions may be more frequent if you are elderly.
In addition, you may experience the following side effects with unknown frequency (frequency cannot
be established based on available data):

• allergic reaction (hypersensitivity)
• severe allergic reaction (anaphylactic shock)
• swelling, sometimes of the face or mouth (angioedema), causing difficulty breathing (angioedema)
• confusional state
• disorientation
• emotional and mood disorders
• decreased libido (sexual desire)
• dependence
• medicine abuse
• withdrawal syndrome
• long-term memory problems (anterograde amnesia)
• memory problems
• drowsiness
• headache
• dizziness
• reduced alertness
• ataxia (reduced motor and gait coordination)
• blurred vision
• diplopia (double vision)
• nausea
• vomiting
• constipation
• problems with the stomach and/or intestines
• skin rash
• itching, urticaria
• muscle weakness
• urinary retention
• fatigue
• falls
• fractures
• respiratory depression (reduced respiratory activity)
• apnea (temporary cessation of breathing)
• worsening of sleep apnea
• heart failure (reduced heart function), including cardiac arrest.
• jaundice (yellow/yellowish discoloration of the skin and mucous membranes and the whites of the eyes)
• alteration of some blood tests (increased bilirubin, transaminases and alkaline phosphatase)
• thrombocytopenia (decreased number of platelets)
• agranulocytosis (decreased number of granulocytes, a type of white blood cells)
• pancytopenia (decreased number of all cells present in the blood)
• syndrome of inappropriate secretion of ADH (antidiuretic hormone) which causes water retention in the body and reduced levels of sodium in the blood

Other side effects that have been reported with other medicines belonging to the
benzodiazepine class, such as BROMAZEPAM PENSA:

• memory disorders (amnesia and anterograde amnesia)
• depression
• insomnia
• rebound anxiety (which occurs after stopping the medicine)
• dependence

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please
contact your doctor or pharmacist. You can also report side effects directly
through the national reporting system at:
https://ww.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the
safety of this medicine.

5. HOW TO STORE BROMAZEPAM PENSA

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the package after SCAD.
The expiry date refers to the last day of that month and to the product in intact packaging,
correctly stored.
This medicine does not require any particular storage conditions.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. PACKAGE CONTENTS AND OTHER INFORMATION

What Bromazepam pensa contains
BROMAZEPAM PENSA 1.5 mg tablets
The active ingredient is bromazepam. Each tablet contains 1.5 mg of bromazepam.
The other ingredients are: microcrystalline cellulose, lactose, talc, magnesium stearate.

BROMAZEPAM PENSA 3 mg tablets
The active ingredient is bromazepam. Each tablet contains 3 mg of bromazepam.
The other ingredients are: microcrystalline cellulose, lactose, talc, magnesium stearate, E172.

BROMAZEPAM PENSA 2.5 mg/ml oral drops, solution
The active ingredient is bromazepam. 1 ml of solution contains 2.5 mg of bromazepam.
The other ingredients are: saccharin, disodium edetate (sequestering agent Na2), mixed fruit flavors, purified water, propylene glycol.

Description of the appearance of Bromazepam Pensa and package contents
BROMAZEPAM PENSA 1.5 mg tablets- Blister containing 20 tablets of 1.5 mg.

BROMAZEPAM PENSA 3 mg tablets- Blister containing 20 tablets of 3 mg.

BROMAZEPAM PENSA 2.5 mg/ml oral drops- Bottle containing 20 ml of solution at 2.5
mg/ml.

BROMAZEPAM PENSA 2.5 mg/ml oral drops- Bottle containing 30 ml of solution at 2.5
mg/ml

Marketing authorisation holder and manufacturer
Marketing authorisation holder
Pensa Pharma S.p.A. – Via Ippolito Rosellini, 12 – 20124 Milan

Manufacturers
Tablets:
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10090 San Bernardo d’Ivrea (TO)
DOPPEL FARMACEUTICI S.p.A. – Via Volturno, 48 – Quinto de’ Stampi – 20089 Rozzano (MI)
Drops:
ABC Farmaceutici S.p.A. – Canton Moretti, 29 – 10090 San Bernardo d’Ivrea (TO)
DOPPEL FARMACEUTICI S.p.A. – Via Martiri delle Foibe, 1 – 29016 Cortemaggiore (PC)

This leaflet was last revised on